What are the Laws that every Doctor should be aware for a safe professional practice?

Here below I have tried to compile a list of some important laws, a few legal cases and related information which may be useful for every Doctor for a safe professional practice. This is not an exhaustive information. Further relevant Acts, Rules and Regulations are to be referred for details. Wherever and in whichever activity the questions of health are involved, generally there are relevant rules, regulations and obligatory guidelines from competent bodies. Further the legislations and interpretations by Courts keep changing with times and we are expected to keep abreast along the same.
Important Laws: 
1.The Karnataka Prohibition of violence against Medicare service personnel and damage to property in Medicare service institutions Act, 2009:  
This Act prohibits violent activities of causing any harm, injury or endangering the life or intimidation, obstruction or hindrance to any Medicare service personnel in discharge of duty in the Medicare service institution or damage to property in Medicare service institution;
Any person who commits violence which will be termed as cognisable and non-bailable shall be punished with imprisonment for a period of three years with fine which may extend to fifty thousand rupees.
In addition to the punishment, the offender shall also be liable to a penalty of twice the amount of property as determined by the Court trying the offender.
2.The Registration of Births and Deaths Act 1969: 
The Medical persons have a duty to notify births and deaths and also certify cause of death to the relevant Registrar of Births and Deaths (normally officers of the local bodies like BBMP etc).
3.Guardians and Wards Act 1890:
In case of minors the consent of the guardian/wards/parents is to be taken wherever necessary.
4.Law of contract Section 13 for consent:
Consent is agreeing upon the same thing in the same sense. Consequently patient should be informed appropriately while taking consent.
5.The Pre-Conception and Prenatal Diagnostic Techniques Act  1994 & Rules 1996:
•Abortion in India is legal only up to twenty weeks of pregnancy under specific conditions and situations.
•One, the continuance of the pregnancy would involve a risk to the life of the pregnant woman or of grave injury of physical or mental health, or
•Two, there is a substantial risk that if the child were born, it would suffer from such physical or mental abnormalities as to be seriously handicapped.
6.Protection of Children from Sexual Offences Act, 2012.
The Act is applicable to all under 18 years of age. Medical care should be provided to them in the presence of parent/guardian or other person in whom the child has trust and confidence.
7.Transplantation of human organ Act 1994, Rules 1995:
This Act regulates removal, storage and transplantation of human organs for therapeutic purposes and prevents commercial dealings relating to human organs.
8.Indian medical termination of pregnancy Act 1971, Rules 2003:
This Act provides for the termination of certain pregnancies. It also aims to improve maternal health scenario by access to safe abortions. This Act is very relevant to Ob & G practitioners.
9.Mental Healthcare Act 2017:

This Act provides for Mental Health Care and Services for persons with mental illness and to safeguard the rights of such patients.
10.The Indian Medical Council Act:
This provides for constitution of MCI, Medical Register and empowers MCI to regulate the professional conduct of Doctors. It has disciplinary powers to issue warning, suspend the registration or award professional death sentence by erasing the name of the practitioner from the Register.
11.IMC (professional conduct, Etiquette and Ethics regulations 2002:
12.Labour laws relating to minimum wages, gratuity act, ESI, PF, Service regulations etc.
13.The radiation surveillance procedures for the medical application of radiation 1989 RADIATION PROTECTION RULES, 1971.
This is relevant for Radiology Doctors.
14.ICMR guidelines for medical research/ clinical trials.
15.Ethical guidelines for biomedical research on human subjects 2000.
16.Consumer protection Act 1986 and Rules 1987, Indian evidence Act 1872 particularly sections 126 to 129 regarding privileged communications, law of torts for vicarious responsibility.
17.There are several laws which deal with the safety of facilities and services against any accidental hazards that may endanger the lives and the liability of managements for any violation. Ex: Boilers Act, Prevention of food adulteration Act etc.

RELEVANT PROVISIONS FOR DOCTORS UNDER INDIAN PENAL CODE, 1860
18.Definitions
Crime or offence means any act or ommission which is contrary to any law or statute for the time being in force.
Summons is the process of court asking the opposite party to appear and answer the allegation preferred by the party who has brought action.
Warrant means an order issued by the court, magistrate or a competent judicial authority, directing a police officer to make arrest, seize or search or to do any other work incidental to administration of justice.
A Warrant case is related to an offence punishable with death, life imprisonment or imprisonment for more than two years. Example: If a doctor helps a pregnant woman in getting rid of the child or to cause its death after its birth.
Cases other than warrant cases are Summons cases. If a doctor acts negligently by using infected syringe or instrument resulting in an infection to an uninfected patient exemplifies a Summons case.
Cognizable offences are those in which a police officer may arrest without warrant, according of Schedule I of Criminal Procedure Code (CPC).
Non-cognizable offences are those in which a police officer can’t arrest without a warrant, e.g. a doctor knowingly disobeying a quarantine rule is liable to be punished with imprisonment upto 6 months or fine.
Bailable Offences are those in which bail can be granted by any law for the time being in force. In such cases bail is matter of right. The court can’t refuse bail and the police has no right to keep the doctor in custody. If any police officer puts a doctor in detention in such cases, he is liable for the offense of wrongful confinement under Sec. 340-342 of IPC(4).
Non-Bailable offences are offences other than the bailable or an offence in which bail can’t be granted. These are the serious offences in which a person may be convicted and imprisoned for term extending more than ten years. For example, offences under transplantation of Human Organ Act 1994.
Presumption of innocence: Law presumes that a person is innocent till his guilt is proved. The onus of proof is on prosecution(5).
Mistake of law: "Ignorentiajuris non excusat, means ignorance of law or mistake of law (existence or mistaken understanding) is not excusable. Erroneous or wrong conclusion of law is not a valid defense. For example, if a doctor carries out prenatal test intended to abort a female fetus, can’t avoid prosecution by saying that I was unaware of any law which punishes such act.
Mistake of fact is a situation where a person not intending to do unlawful act, does so because of wrong conclusion or understanding of fact. The guilty mind was never there while doing the act. The person may not be held responsible in such cases.
Res Judicata: This doctrine of law means "the things have been decided". According to this principle, once the case is completed between two parties, it cannot be tried again between the same parties. Suppose a patient sues a hospital for any wrong, damages or malpractice and the things are decided, he cannot subsequently sue the doctor again separately for the same negligence.
Res Ipsa Loquitur is a situation of gross negligence or rashness. The things are so obvious that they "speak for themselves". Most of the time there is no need for any proof of negligence in such cases. Common examples include giving blood transfusion to wrong patient, or operating on wrong side of the body or wrong patient.

Consent in Criminal Law (Sec. 90 IPC)
A valid consent must be given voluntarily, by an adult who is not of unsound mind. The consent must be given after reasonable understanding and without any misrepresentation or hiding of the facts. Thus the consent should be an informed consent, preferably in writing and in presence of witnesses. All components of valid consent are applicable even for the consent in criminal law. According to criminal law, it is an offence to cause injury to any person even with his consent. No person has right to give consent to suffer death or grievous hurt. This point has to be kept in mind especially during cases of organ transplantation. The donor may have given consent under family, social or financial pressures. In cases of dead donors if there is no expressed will, the body is the property of the heirs and their consent is required.
Sec. 276 Whoever knowingly issues from a dispensary for medical purpose any drug as a different drug or preparation is liable for punishment.
Sec. 269-271: Related to spread of infectious disease and disobedience of a quarantine rule.
Sec. 304-A: Deals with death caused by a negligent act. Whoever causes the death by rash or negligence act but not amounting to culpable homicide will be punished with imprisonment up to two years or fine or with both.
Sec. 304 and 304-A:  There is lot of discrepancy while applying these sections in cases of professional negligence by doctors. Most of the times the police authorities register the cases of professional negligence deaths under Sec. 304 of IPC. According to this Section the offence is non-bailable. This causes lot of hardship, bad reputation and mental agony to the doctors. In fact the police should register the cases of deaths due to medical negligence under Sec. 304-A of IPC, in which the offence is bailable and the doctor can be released on bail. The judgment has been passed by Bombay High Court in Criminal Revision application no. 282 of 1996 (Dr. Mrs. Mrudula S. Deshpandevs State of Maharashtra) dated 28th November 1998(3). The basic difference is that in Sec. 304 there is intentional act of negligence while in 304-A the act is never done with the intention to cause death.
Sec. 306 to 309: Relates to abetment of suicide.
Sec. 312 to 314: Relates to causing mis-carriage, abortion
and hiding such facts.
Sec. 315-316: Deals with act to prevent child being born alive or to cause death after birth.
Sec. 319 to 322: Related to causing hurt, loss of vision, hearing or disfigurement.
Sec. 336 to 338: Deals with causing hurt by rash or negligent act.
Sec 340 to 342: Relates to wrongful confinement.
Sec 491: Relates to breach contract like for a helpless person.
Sec 499: Relates to defamation.
Other issues under the criminal law: 
According to the provisions of Indian Penal Code 1860 (IPC) any act of commission or omission is not a crime unless it is accompanied by a guilty mind (MENS REA).
Most of the times doctors treatment is in good faith, with the consent of the patient and hence most of the provisions of IPC are not applicable to the doctors unless or until there is rashness or gross negligence.
When to Inform Police
A doctor has to inform the police in following circumstances.  Failure to inform police in such cases may result in penal consequences. Police must be informed in (i) cases of suspected homicide, (ii) cases of suicidal deaths, (iii) unknown, unconscious patient, (iv) death on operation table, (v) suspected unnatural death, (vi) sudden, unexpected, violent and unexplained death, (vii) instant death after treatment or reaction of medicine, and a (viii) married lady dying within seven years of marriage due to any reason.
It is advisable to inform police in following circumstances (i) undiagnosed death within 24 hrs. of admission or specially if there is any suspicion, (ii) any cases of poisoning, (iii) accidental deaths, and (iv) in cases of hospital deaths if (a) accidents not related to medical management like fall from staircase etc., though there is no legal obligation on doctor, it is advisable to inform the police, (b) unexpected or rare complications may occur sometimes, e.g. a child may vomit, aspirate the content and may die. This is very unpredictable and it is not obligatory on part of the doctor to inform such deaths. But it is better if we inform the police because sometimes patient’s relatives may allege negligence in such cases. In cases of death due to negligence in treatment there are no specific provisions to inform the police but in order to avoid untoward incidences it is better to inform the police.
"Brought dead cases": In such cases, if the cause of death is apparent and there are no reasonable grounds to suspect some medico-legal complications then it is not necessary to inform the police. If the cause of death can’t be ascertained in any case then it is desirable to send the body for postmortem examination preferably with the help of the police. It is advisable to suggest postmortem in the following circumstances: (i) whenever death is sudden, unexpected or unexplained, (ii) accidental deaths which may be roadside, domestic or industrial, (iii) when precise cause of death is needed for insurance claim purposes etc., and (iv)  as a help to arrive at final diagnosis.
Information to police shall preferably be in writing and the written acknowledgement should be obtained. If the information is telephonic one must note down name, buckle number and designation of the police.
Can a Doctor be arrested?
Doctors have no immunity against arrest (as any other citizen of India) for the various criminal acts as per the provisions of IPC or CPC of India.
Illegal organ trading, unlawful sex determination etc. are non-bailable offenses. But the question is whether a doctor be arrested for:
(a) Alleged medical negligence during day to day care of a patient,
(b) Unexplained hospital deaths like SIDS etc.
(c) Postoperative complication or failure of operation;
(d) Not attending or refusing a patient (who was not already under his care) who becomes serious or dies and
(e) not attending a case of roadside accident.
Recently, the chairman of a hospital was arrested for not complying with the Supreme Court directives in a roadside accident. In this particular case the patient died while being shifted to other hospital. The Supreme Court directives (criminal writ petition no. 270 of 1988) in a roadside accident include:
• The medical aid should be instantaneous. It is the duty of the registered medical practitioner to attend the injured and render medical aid, treatment without waiting for procedural formalities unless the injured person or guardian (in case of minor) desires otherwise.
• The effort to save the person and preserve the life, should be top priority, not only of the doctor but also of the police officer or any other citizen who happens to notice such an accident.
• The professional obligation of protecting life extends to every doctor, whether at Government hospital or otherwise.
• The obligation being total, absolute and paramount, no statutory or procedural formalities can interfere in discharging this duty.
• Whenever better or specific assistance is required, it is the duty of treating doctor to see that the patient reaches the proper expert as early as possible.
• Non-compliance of these directives may invite prosecution under provisions of Motor Vehicle Act or IPC (7).
If FIR is lodged by patient or relatives then the police may arrest the doctor. Hence better approach in cases where we feel that the patients or relatives may create nuisance will be as follows:
1. The doctor should lodge a FIR that a particular incidence has happened in my hospital.
Legal Rights of an Arrested Person
The arrested person shall be communicated with the particulars of offence and the ground for arrest. If the offense is bailable, then the person should be informed and the arrangement for the bail may be made. If the police officer refuses to release such person on bail, he will be liable for damages for wrongful confinement. Sometimes a police officer may register an offense under Sec. 304 of IPC instead of 304-A in order to detain the accused doctor. In such cases officer may have to face serious consequences. The person shall not be subjected to more restraint than necessary to prevent his escape. If there are any offensive weapons belonging to the arrested person, these weapons may be seized. The arrested person must be produced before a magistrate having jurisdiction in that case. No police officer shall detain in custody an arrested person for more than 24 hours unless a special order from a magistrate is obtained(9).
Anticipatory Bail: In order to avoid frivolous accusations, there is provision of anticipatory bail. This may be granted as a protection in offences which are non-bailable. It is direction to release applicant on bail, if there is arrest. Once granted it remains in force. Pre-requisites for anticipatory bail are: (i) there must be reasonable apprehension of arrest, (ii) the alleged offence must be non-bailable, and (iii) the registration of FIR is not necessary.
Procedure for Bail: The accused is required to execute his personal bond at the police station with or without surety. The surety may be a close relative, a friend or a neighbor, who is required to undertake to pay the said amount in case of absconding of the accused.

Dos and Don’ts
•Inform police whenever necessary.
•Extend all possible co-operation to the police.
•Furnish copies of medical records to police, court or relatives whenever demanded. Consent of patient may be taken while providing information to police.
•Follow the legal procedures or provisions.
•Have a valid informed consent for the treatment (10).
•Preserve the documents, records especially in medico-legal, controversial or complicated cases.
•Insist for post-mortem examination if the cause of death can’t be ascertained.
•Involve medical associations, medico-legal cells and voluntary organizations whenever legal problem arises.
•Consult your lawyer before giving any reply.
•Don’t become panicky.
•Don't manipulate or tamper with the documents.
•Don’t do unlawful or unethical acts.
•Don’t issue false or bogus certificates. Certificate was issued on request is no defence.
•Don’t neglect the treatment while completing legal formalities especially in serious or emergency situation.
The Supreme Court in the case of medical negligence held as under:
“Jacob Mathew vs State of Punjab & Another ”:
•Negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do. The definition of negligence as given in Law of Torts, Ratanlal & Dhirajlal (edited by Justice G.P. Singh), referred to hereinabove, holds good. Negligence becomes actionable on account of injury resulting from the act or omission amounting to negligence attributable to the person sued. The essential components of negligence are three: 'duty', 'breach' and 'resulting damage'.
•Negligence in the context of medical profession necessarily calls for a treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of care, an error of judgment or an accident, is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed. When it comes to the failure of taking precautions what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient; a failure to use special or extraordinary precautions which might have prevented the particular happening cannot be the standard for judging the alleged negligence. So also, the standard of care, while assessing the practice as adopted, is judged in the light of knowledge available at the time of the incident, and not at the date of trial. Similarly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that particular time (that is, the time of the incident) at which it is suggested it should have been used.
•A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.
•The test for determining medical negligence as laid down in Bolam's case [1957] 1 W.L.R. 582, 586 holds good in its applicability in India.
•The jurisprudential concept of negligence differs in civil and criminal law. What may be negligence in civil law may not necessarily be negligence in criminal law. For negligence to amount to an offence, the element of men’s rea must be shown to exist. For an act to amount to criminal negligence, the degree of negligence should be much higher i.e. gross or of a very high degree. Negligence which is neither gross nor of a higher degree may provide a ground for action in civil law but cannot form the basis for prosecution.
•The word 'gross' has not been used in Section 304A of IPC, yet it is settled that in criminal law negligence or recklessness, to be so held, must be of such a high degree as to be 'gross'. The expression 'rash or negligent act' as occurring in Section 304A of the IPC has to be read as qualified by the word 'grossly'.
•To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed to do something which in the given facts and circumstances no medical professional in his ordinary senses and prudence would have done or failed to do. The hazard taken by the accused doctor should be of such a nature that the injury which resulted was most likely imminent.
•Res ipsa loquitur is only a rule of evidence and operates in the domain of civil law especially in cases of torts and helps in determining the onus of proof in actions relating to negligence. It cannot be pressed in service for determining per se the liability for negligence within the domain of criminal law. Res ipsa loquitur has, if at all, a limited application in trial on a charge of criminal negligence.
“Martin D’Souza vs Mohammed Isfaq”
The bench of Justices Markandeya Katju & R M Lodha ruled that “courts must first refer complaints of medical negligence to a competent doctor or a panel of experts in the field before issuing notice to the allegedly negligent doctor. This is necessary to avoid harassment to doctors who may not be ultimately found to be negligent. We further warn the police officials not to arrest or harass doctors unless the facts clearly come within the parameter laid down in Jacob Mathew’s case, otherwise the policemen will themselves have to face legal action”.

Medico-Legal cases:
The following are normally referred as medico legal cases. I.e. where both medical and legal aspects are involved. Ex:  accidents, unnatural mishaps, homicides or suicides or their attempts, positioning, burn injuries, injuries/unconsciousness due to foul play, sexual offences, criminal abortions, cases brought dead with improper history, cases referred by courts etc.
Illustrations:
1.In one case the Doctor was charged with the allegation that he refused to talk to the patient or his attendants even for two minutes during every visit. KMC took a lenient view of the case because the Doctor defended stating that the diagnostic report was exhaustive and there was no need for discussion with them. Since the matter was not escalated to the judicial forums the case stood closed.
2.In another case a splinter of the broken scissor during the operation was left inside the body of the patient. Another Doctor successfully extricated it.  The Consumer Court levied a heavy penalty on the first operating Doctor considering medical negligence. 
3.A major operation was conducted on the patient. But there was absolutely no improvement in the health status of the patient. This was considered as medical negligence.
4.In the land mark judgement between Samira Kohli Vs Dr. Prabha Manchanda, hysterectomy was conducted on Ms. Samira with due consent from herself and her mother as it was essential to do due to advanced stage of endometriosis. Her boyfriend approached the National Consumer Disputes Redressal Forum (on many grounds like loss of reproductive capacity and diminished matrimonial prospects etc.) which held in favour of Dr. Manchanda.
5.In another land mark judgement between Suresh Gupta Vs Govt. of NCT of New Delhi a young patient of 38 years was operated by the Doctor for removing his nasal deformity. The assistance of an anaesthetist was taken. But the patient suffered cardiac arrest on the table. The patient was under supporting respirations and shifted to the ICU of another Hospital. A criminal case was instituted against the Doctor and the anaesthetist. During the pendency of trial the anaesthetist died. The Metro Politian Magistrate ordered criminal proceedings against the Doctor with the view that while conducting minor operation the incision was given at wrong part due to which the blood seeped in to the respiratory passage etc. In appeal the High Court refused to quash the criminal proceedings. However the Supreme Court held that the Doctor may be liable for tort but is not criminally liable because no case of gross negligence was made out.  
6.The following are a few Illustrations for professional misconduct, medical negligence and deficiency in service:
•Injecting wrong drug or right drug but in over dosage leading to irreversible side effects. Injecting wrong dosage of Anaesthesia.
•Amputation and operating of wrong limb and removal of organs without patient consent.
•Operating on the incorrect patient.
•Leaving medical instruments and foreign objects behind during operation.
•Leaving stitches behind for a longer period leading to gangrene and infection.

•Transfusing wrong or infected blood
•Applying faulty plasters leading to lifetime distortion & damages.
•Performing foetus sex determination & illegal abortions

Other important issues:
The growing mistrust among patients and their attendants on their treating doctors is emerging as the biggest challenge in the cure of diseases. The abuse may range from verbal abuses, manhandles, physical assaults, threatening and in rare cases murder. Matters worsen when medical casualty’s outbreaks into public outrages causing humiliation and threat to the lives of medical professionals.
Civil law and negligence
Public awareness of medical negligence in India is growing. Hospital managements are increasingly facing complaints regarding the facilities, standards of professional competence, and the appropriateness of their therapeutic and diagnostic methods.
Negligence is the breach of a legal duty to care. It means carelessness in a matter in which the law mandates carefulness. A breach of this duty gives a patient the right to initiate action against negligence.
Persons who offer medical advice and treatment implicitly state that they have the skill and knowledge to do so, that they have the skill to decide whether to take a case, to decide the treatment, and to administer that treatment. This is known as an “implied undertaking” on the part of a medical professional. In the case of the State of Haryana vs Smt Santra, the Supreme Court held that every doctor “has a duty to act with a reasonable degree of care and skill”
Doctors in India may be held liable for their services individually or vicariously unless they come within the exceptions specified in the case of Indian Medical Association vs V P Santha. Doctors are not liable for their services individually or vicariously if they do not charge fees. Thus free treatment at a non-government hospital, governmental hospital, health centre, dispensary or nursing home would not be considered a “service” as defined in Section 2 (1) (0) of the Consumer Protection Act, 1986.
However, no human being is perfect and even the most renowned specialist could make a mistake in detecting or diagnosing the true nature of a disease. A doctor can be held liable for negligence only if one can prove that she/ he is guilty of a failure that no doctor with ordinary skills would be guilty of if acting with reasonable care. An error of judgement constitutes negligence only if a reasonably competent professional with the standard skills that the defendant professes to have, and acting with ordinary care, would not have made the same error.
In a key decision on this matter in the case of Dr Laxman Balkrishna Joshi vs Dr Trimbak Bapu Godbole, the Supreme Court held that if a doctor has adopted a practice that is considered “proper” by a reasonable body of medical professionals who are skilled in that particular field, he or she will not be held negligent only because something went wrong.
Doctors must exercise an ordinary degree of skill. However, they cannot give a warranty of the perfection of their skill or a guarantee of cure. If the doctor has adopted the right course of treatment, if she/ he is skilled and has worked with a method and manner best suited to the patient, she/ he cannot be blamed for negligence if the patient is not totally cured.
Certain conditions must be satisfied before liability can be considered. The person who is accused must have committed an act of omission or commission; this act must have been in breach of the person’s duty; and this must have caused harm to the injured person. The complainant must prove the allegation against the doctor by citing the best evidence available in medical science and by presenting expert opinion.
In some situations the complainant can invoke the principle of res ispa loquitur or “the thing speaks for itself”. In certain circumstances no proof of negligence is required beyond the accident itself. The National Consumer Disputes Redressal Commission applied this principle in Dr Janak Kantimathi Nathan vs Murlidhar Eknath Masane.
The principle of res ipsa loquitur comes into operation only when there is proof that the occurrence was unexpected, that the accident could not have happened without negligence and lapses on the part of the doctor, and that the circumstances conclusively show that the doctor and not any other person was negligent.
Criminal negligence
Section 304A of the Indian Penal Code of 1860 states that whoever causes the death of a person by a rash or negligent act not amounting to culpable homicide shall be punished with imprisonment for a term of two years, or with a fine, or with both.
In the Santra case, the Supreme Court has pointed out that liability in civil law is based upon the amount of damages incurred; in criminal law, the amount and degree of negligence is a factor in determining liability. However, certain elements must be established to determine criminal liability in any particular case, the motive of the offence, the magnitude of the offence, and the character of the offender.
In Poonam Verma vs Ashwin Patel the Supreme Court distinguished between negligence, rashness, and recklessness. A negligent person is one who inadvertently commits an act of omission and violates a positive duty. A person who is rash knows the consequences but foolishly thinks that they will not occur as a result of her/ his act. A reckless person knows the consequences but does not care whether or not they result from her/ his act. Any conduct falling short of recklessness and deliberate wrongdoing should not be the subject of criminal liability.
Thus a doctor cannot be held criminally responsible for a patient’s death unless it is shown that she/ he was negligent or incompetent, with such disregard for the life and safety of his patient that it amounted to a crime against the State.
Sections 80 and 88 of the Indian Penal Code contain defences for doctors accused of criminal liability. Under Section 80 (accident in doing a lawful act) nothing is an offence that is done by accident or misfortune and without any criminal intention or knowledge in the doing of a lawful act in a lawful manner by lawful means and with proper care and caution. According to Section 88, a person cannot be accused of an offence if she/ he performs an act in good faith for the other’s benefit, does not intend to cause harm even if there is a risk, and the patient has explicitly or implicitly given consent.

Burden of proof and chances of error
The burden of proof of negligence, carelessness, or insufficiency generally lies with the complainant. The law requires a higher standard of evidence than otherwise, to support an allegation of negligence against a doctor. In cases of medical negligence the patient must establish her/ his claim against the doctor.
In Calcutta Medical Research Institute vs Bimalesh Chatterjee it was held that the onus of proving negligence and the resultant deficiency in service was clearly on the complainant. In Kanhaiya Kumar Singh vs Park Medicare & Research Centre, it was held that negligence has to be established and cannot be presumed.
Even after adopting all medical procedures as prescribed, a qualified Doctor may commit an error. The National Consumer Disputes Redressal Commission and the Supreme Court have held, in several decisions, that a doctor is not liable for negligence or medical deficiency if some wrong is caused in her/ his treatment or in her/ his diagnosis if she/ he has acted in accordance with the practice accepted as proper by a reasonable body of medical professionals skilled in that particular art, though the result may be wrong. In various kinds of medical and surgical treatment, the likelihood of an accident leading to death cannot be ruled out. It is implied that a patient willingly takes such a risk as part of the doctor-patient relationship and the attendant mutual trust.
A few other Supreme Court rulings
Before the case of Jacob Mathew vs State of Punjab, the Supreme Court of India delivered two different opinions on doctors’ liability. In Mohanan vs Prabha G Nair and another, it ruled that a doctor’s negligence could be ascertained only by scanning the material and expert evidence that might be presented during a trial. In Suresh Gupta’s case in August 2004 the standard of negligence that had to be proved to fix a doctor’s or surgeon’s criminal liability was set at “gross negligence” or “recklessness.”
In Suresh Gupta’s case the Supreme Court distinguished between an error of judgement and culpable negligence. It held that criminal prosecution of doctors without adequate medical opinion pointing to their guilt would do great disservice to the community. A doctor cannot be tried for culpable or criminal negligence in all cases of medical mishaps or misfortunes.
A doctor may be liable in a civil case for negligence but mere carelessness or want of due attention and skill cannot be described as so reckless or grossly negligent as to make her/ him criminally liable. The courts held that this distinction was necessary so that the hazards of medical professionals being exposed to civil liability may not unreasonably extend to criminal liability and expose them to the risk of imprisonment for alleged criminal negligence.
Hence the complaint against the doctor must show negligence or rashness of such a degree as to indicate a mental state that can be described as totally apathetic towards the patient. Such gross negligence alone is punishable.
On September 9, 2004, Justices Arijit Pasayat and CK Thakker referred the question of medical negligence to a larger Bench of the Supreme Court. They observed that words such as “gross”, “reckless”, “competence”, and “indifference” did not occur anywhere in the definition of “negligence” under Section 304A of the Indian Penal Code and hence they could not agree with the judgement delivered in the case of Dr Suresh Gupta.
The issue was decided in the Supreme Court in the case of Jacob Mathew vs State of Punjab. The court directed the central government to frame guidelines to save doctors from unnecessary harassment and undue pressure in performing their duties. It ruled that until the government framed such guidelines, the following guidelines would prevail:
A private complaint of rashness or negligence against a doctor may not be entertained without prima facie evidence in the form of a credible opinion of another competent doctor supporting the charge. In addition, the investigating officer should give an independent opinion, preferably of a government doctor. Finally, a doctor may be arrested only if the investigating officer believes that she/ he would not be available for prosecution unless arrested.
Law governing professional misconduct by doctors
The Indian Medical Council Act, 1956 empowers MCI (Medical Council of India) to make regulations for the professional conduct of doctors. The Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, notified by the MCI in 2002 governs the regulation of professional conduct, ethics, and etiquettes for registered medical professionals.
Duties of physicians to their patients
A physician is not bound to treat each and every person asking for his services, but he should always be ready to respond to the calls of injured and sick. He must show patience and delicacy towards his patients. Secrecy of medical dispositions of the patient must be maintained unless required to be revealed by law of the land. He should neither exaggerate nor minimize the gravity of patient’s condition. He should not neglect a patient once admitted.
Not taking consent of patient
Performing an operation without taking the consent in writing from the husband or wife, parent or guardian in the case of a minor, or the patient himself as the case may be, constitutes misconduct. In an operation which may result in sterility, the consent of both husband and wife is needed.
Publishing photographs or case reports of patients without their permission, in any medical or other journals in a manner by which their identity could be made out is punishable.
In an operation which may result in sterility consent of husband and wife, both are needed.
Informed consent of female and her spouse must be taken before in-vitro fertilization or artificial insemination.

Criminal Liability for professional misconduct by doctors
Criminal liability for medical negligence may be imposed on one of the two findings:-
1. the doctor was not possessed of the requisite skill which he professed to have possessed, or,
2. He did not exercise, with reasonable competence in the given case, the skill which he did possess.
For imposing criminal liability a very high degree of negligence is required to be proved.
Criminal liability is imposed generally in cases of medical negligence as per the provisions of the Indian Penal Code. Section 304A (Death due to negligence) [7], section 337 (causing hurt) [8] and section 338 (causing grievous hurt)[9] are often applied to deal with cases of medical negligence.
Prenatal sex determination except for the purpose of diagnosing abnormalities and diseases attracts an imprisonment up to three years. [10]
Civil Liability for professional misconduct by doctors
Simple lack of care by practitioner constitutes a civil liability.[11] An action seeking imposition of civil liabilities i.e. monetary compensation can be initiated by either the patient or his/her dependents before appropriate Civil Courts or consumer forums. Doors of Lok Adalats can also be knocked at by the complainant.
The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 have a bearing on professional misconduct and Medical negligence also.
The medical council can take following actions if professional misconduct is established during inquiry:-
1. It may pardon the practitioner.
2. Pleading guilty with an intention to get less punishment may result in being pardoned or merit a warning.
3. It can order the practitioner to apologize publicly or to the aggrieved.
4. It may award a compensation to the complainant.
5. It may issue a warning to the practitioner.
6. It may temporarily restrict the doctor from performing certain procedures or seeing certain types of patients.
7. It may temporarily suspend the license to practice.
8. It may permanently suspend the license to practice.
9. It may refer the matter to the police for inquiry under relevant IPC sections [19]
Appeal and Limitation
A person aggrieved by the decision of State Medical Council can file an appeal to the Medical Council of India within 60 days from the date of receipt of the order passed by State Medical Council. Further extension may be granted by the MCI if it is satisfied that the appellant was prevented by sufficient cause from filing the appeal within 60 days.

Maintenance of medical records:
Every physician shall maintain the medical records pertaining to his/her patients for a period of three years from the date of commencement of the treatment in standard formats laid down by the medical Council of India.
Information to patients:
The patient has the absolute right to know about his/her disease, diagnosis, plan of treatment, type of anesthesia, alternate treatments available, risks involved, the benefits of the treatment, cost of the treatment and such connected information.
Prognosis:
The physician should neither exaggerate nor minimize the gravity of a patient’s condition. He should ensure himself that the patient, his relatives or his responsible friends have such knowledge of the patient’s condition as will serve the best interests of the patient and the family.


Professional indemnity
Professional indemnity should be obtained and continuously maintained in a valid state by prompt payment of Premiums.
Deficiency in service:
Sec.2 (1) (g) of the Consumer Protection Act 1996 defines deficiency of service:   "Deficiency" means any fault, imperfection, shortcoming or inade¬quacy in the quality, nature and manner of performance which is required to be maintained by or under any law for the time being in force or has been undertaken to be performed by a person in pursuance of a contract or otherwise in relation to any service
List of Certificates normally issued by the Doctors under different Acts and Rules:
a. Under the Acts relating to birth, death or disposal of the dead.
b. Under the Acts relating to Lunacy and Mental Deficiency and under the Mental illness Act and the rules made thereunder.
c. Under the vaccination Acts and the regulations made thereunder.
d. Under the Factory Acts and the regulations made thereunder.
e. Under the Education Acts.
f. Under the Public Health Acts and the orders made thereunder.
g. Under the Workmen’s Compensation Act and Persons with Disability Act.
h. Under the Acts and orders relating to the notification of infectious diseases.
i. Under the Employee’s State Insurance Act.
j. In connection with sic benefit insurance and friendly societies.
k. Under the Merchant Shipping Act.
l. For procuring/issuing of passports.
m. For excusing attendance in courts of Justice, in public services, in public offices or in ordinary employment.
n. In connection with Civil and Military matters.
o. In connection with matters under the control of Department of Pensions.
p. In connection with quarantine rules.
q. For procuring driving licence.


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